MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 314-02-03 - equinoxe glenoid, pegged alpha, medium 300-10-45 - equinoxe replicator plate 4.5mm o/s 310-01-44 - equinoxe, humeral head short, 44mm (alpha) 300-20-02 - equinox square torque define screw drive kit should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that during a revision procedure, the patient¿s greater tuberosity broke while trying to remove the stem.The surgeon explained to the patient they will probably require a hrp as part of the 2nd stage revision.There were device breakages and there were fragments, parts, pieced in the wound site which were removed by the surgeon and a wash out occurred.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were available.This is 1 of 2 events for this patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5, h6, h11.The complaint device was evaluated, and the reported event was not confirmed.The stem was returned for evaluation, and images were provided.The returned stem appears unremarkable for an explanted component.There appears to be residual bone attached to the device as well as scratching consistent with tool damage created during removal.A review of complaint history determined that no further action is required as no trends were identified.The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition or high forces during retraction.However, this cannot be confirmed based on the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
The patient had a previous stemmed anatomic shoulder replacement which was revised.The surgeon removed all implants and inserted a cement spacer preparing for the 2nd stage revision which the patient will come back for.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23287498
• Report Number: 1038671-2025-03099
• Device Sequence Number: 12139171
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown